Comparison · NCT01919697-c5cc2cf4
Plecanatide 3 mg vs Plecantide 6 mg: Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Plecanatide 3 mg vs Plecantide 6 mg: Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline. Trial comparisons, record NCT01919697-c5cc2cf4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01919697-c5cc2cf4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.857 | 0.805 | 0.897 | wilson | |
| Risk in group 2 | 0.698 | 0.678 | 0.717 | wilson | |
| Risk difference, group 1 minus group 2 | 0.159 | 0.104 | 0.204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 1.16 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 2.6 | 1.77 | 3.82 | log | |
| Number needed to treat, for one more participant with the outcome on Plecanatide 3 mg than on Plecantide 6 mg | 6.29 | 4.91 | 9.63 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Plecanatide 3 mg | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | 192 | 224 | OG000 |
| Group 2 | Plecantide 6 mg | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks | 1,498 | 2,146 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline
- Description
Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.
- Time frame
- From first dose up to 72 weeks
- Population
- This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.
Source ClinicalTrials.gov
Trial
- Title
- Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
- NCT number
- NCT01919697
- Phases
- PHASE3
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Plecanatide
- Lead sponsor
- Bausch Health Americas, Inc.
- Results first posted
- 2019-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01919697?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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